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RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy

NCT06930092 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-04-24

No results posted yet for this study

Summary

To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.

Conditions

  • Ischemic Cardiomyopathy

Interventions

PROCEDURE

Physiology-and imaging-guided PCI

The criteria for performing revascularization are as follows 1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (\>90%) 2. In vessels meeting the above criteria, IVUS findings consistent with either: * Minimum lumen area (MLA) ≤ 3 mm² * 3 mm² \< MLA ≤ 4 mm² and plaque burden \>70% For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them: 1. Post-PCI FFR \> 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR \> 0.80 to achieve functional complete revascularization. 2. Post-PCI ΔFFR (defined as \[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05 is recommended. 3. On IVUS, achieving a minimum stent area (MSA) \> 5.5 mm² and MSA/average reference lumen \> 80% is recommended.

DRUG

Optimal medical treatment

All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Seoul National University Boramae Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-03
Primary Completion
2028-04-30
Completion
2029-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930092 on ClinicalTrials.gov